An Extension Study Evaluating the Long-Term Safety and Tolerability of Degarelix One-Month Depots in Prostate Cancer
An Open-Label, Multi-Centre, Extension Study Evaluating the Long-Term Safety and Tolerability of Degarelix One-Month Depots in Patients With Prostate Cancer.
1 other identifier
interventional
137
7 countries
34
Brief Summary
This was an extension study for the study FE200486 CS12 (NCT00819156). Each participant was to be treated until he was discontinued or withdrawn from the study, or a marketing authorization for degarelix had been obtained. The study was terminated when all ongoing participants had been treated for at least 5 years (including one year in the main study).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 prostate-cancer
Started Feb 2005
Typical duration for phase_2 prostate-cancer
34 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2005
CompletedFirst Submitted
Initial submission to the registry
September 20, 2005
CompletedFirst Posted
Study publicly available on registry
September 22, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2009
CompletedResults Posted
Study results publicly available
December 14, 2010
CompletedApril 1, 2015
March 1, 2015
4.7 years
September 20, 2005
November 12, 2010
March 12, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Participants With Markedly Abnormal Change in Vital Signs and Body Weight
Vital signs and body weight included incidence of markedly abnormal changes in blood pressure (systolic and diastolic), pulse, and body weight at the end of trial as compared to baseline. The table presents the number of participants in each group with normal baseline and markedly abnormal value post-baseline.
5 years
Liver Function Tests
The figures present the number of participants who had abnormal (defined as above upper limit of normal range (ULN)) alanine aminotransferase (ALT) levels, aspartate aminotransferase levels, and bilirubin levels plus the number of participants who had ALT increases \>3x ULN and ALT increases \>3x ULN with concurrently increased bilirubin \>1.5 ULN.
5 years
Study Arms (3)
Degarelix 80 mg
EXPERIMENTALParticipants who completed the CS12 study in the Degarelix 80 mg arm continued that dose into the CS12A extension study. After a protocol amendment in January 2006 all study participants were treated with 160 mg (40 mg/mL).
Degarelix 120 mg
EXPERIMENTALParticipants who completed the CS12 study in the Degarelix 120 mg arm continued that dose into the CS12A extension study. After a protocol amendment in January 2006 all study participants were treated with 160 mg (40 mg/mL).
Degarelix 160 mg
EXPERIMENTALParticipants who completed the CS12 study in the Degarelix 160 mg arm continued that dose into the CS12A extension study. After a protocol amendment in January 2006 all study participants were treated with 160 mg (40 mg/mL).
Interventions
Drug supplied as a powder to be dissolved in the solvent for solution for injection. Degarelix given by subcutaneous injection every 28 days until the end of the study.
Eligibility Criteria
You may qualify if:
- Had given written consent before any study-related activity was performed (a study-related activity was defined as any procedure that would not have been performed during the normal management of the participant)
- Had completed the FE200486 CS12 study
- Had been withdrawn from the FE200486 CS12 study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (34)
UCL Saint Luc
Brussels, Belgium
UZ Gent
Ghent, Belgium
UZ Gasthuisberg, Urology Department
Leuven, Belgium
Vivantes Klinikum am Urban, Klinik für Urologie
Berlin, Germany
Urologische Universitätsklinikum, Klinikum Mannheim GmbH, Fakultät für Klinische Medizin Mannheim
Mannheim, Germany
Bajcsy-Zsilinszky Hospital, of local Government of Budapest, Dept. of Urology
Budapest, Hungary
Jahn Ferenc Dél-Pesti Hospital, Dept. of Urology
Budapest, Hungary
Pez Aladar County Hospital, Dept. of Urology
Győr, Hungary
Bács-Kiskun County Hospital, Dept. of Urology
Kecskemét, Hungary
BAZ County Hospital, Dept of Urology
Miskolc, Hungary
Hospital of Local Government of Szeged, Dept. of Urology
Szeged, Hungary
MÁV Hospital, Dept. of Urology
Szolnok, Hungary
Academic Medical Center, Dept. of Urology
Amsterdam, Netherlands
Atrium MC, Dept. of Urology
Heerlen, Netherlands
"Prof.Dr.Th.Burghele" Hospital - Bucharest
Bucharest, Romania
"Sf. Ioan" Emergency Hospital - Urology Department
Bucharest, Romania
CF2 Hospital - Bucharest, Urology Department
Bucharest, Romania
Fundeni Clinical Institute - Bucharest, Urology Department
Bucharest, Romania
Moscow State University of Medicine and Dentistry, Department of Urology, Urogynecology and Andrology, City Hospital #50, Urology Department
Moscow, Russia
Russian Medical Academy of Postgraduate Education, Department of Gerontolology and Geriatrics, Moscow City Hospital #60, Urology Department, 84/1, Entuziastov Shosse (Hospital)
Moscow, Russia
Russian Medical Academy of Postgraduate Education, Urology Department, Moscow Clinical Hospital n.a. Botkin, Urology Department, 5/16, 2-oy Botkinsky proezd (Hospital)
Moscow, Russia
Russian State Medical University, Department of Urology and Surgical Nephrology, Moscow City Hospital #1
Moscow, Russia
"Andros" Urology Clinic, 36A, Lenina St.
Saint Petersburg, 197136, Russia
City Hospital #15, Urology Department
Saint Petersburg, Russia
City Hospital #26, Urology Department
Saint Petersburg, Russia
I.I. Mechnikov St. Petersburg State Medical Academy, Urology Department
Saint Petersburg, Russia
Research Institute of Urology of the Ministry of Healthcare of the Russian Federation
Saint Petersburg, Russia
St. Petersburg Pavlov Medical School, Urology Department
Saint Petersburg, Russia
St.Petersburg Pavlov Medical School, Outpatient Diagnostic Center
Saint Petersburg, Russia
Glenwood Hospital
Durban, South Africa
WITS Medical School, Level 9
Parktown, South Africa
401 B Medical Centre
Pietermaritzburg, South Africa
Pretoria Urology Hospital, Suite 2, Hatfield
Pretoria, South Africa
Sunninghill Clinic, Suite 3
Sunninghill, South Africa
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Ferring Pharmaceuticals
- Organization
- Clinical Development Support
Study Officials
- STUDY DIRECTOR
Clinical Development Support
Ferring Pharmaceuticals
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 20, 2005
First Posted
September 22, 2005
Study Start
February 1, 2005
Primary Completion
October 1, 2009
Study Completion
November 1, 2009
Last Updated
April 1, 2015
Results First Posted
December 14, 2010
Record last verified: 2015-03